Z-2080-2014Class II

Disposable StrykeFlow Tip, Stryker Disposable Suction/I irrigator Tip; Sterile, Rx only, Latex Free. Stryker...

Name: Z-2080-2014 Disposable StrykeFlow Tip, Stryker Disposable Suction/I irrigator Tip; Sterile, Rx only, Latex Free. Stryker...
Creator: Stryker Endoscopy
Published: 2014-06-20
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2014-06-20 / Terminated / root cause: packaging

FDA source

Stryker Endoscopy began a recall of Disposable StrykeFlow Tip, Stryker Disposable Suction/I irrigator Tip; Sterile, Rx only, Latex Free. Stryker Suction Irrigation system, used to provide a clean... on 2014-06-20. FDA classified it as Class II and gives the reason as "Internal review found that six lots of Disposable StrykeFlow Tips were shipped with a potentially deformed blister pouch which could impact sterility of the product". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2080-2014
Classification: Class II
Status: Terminated
Initiated: 2014-06-20
Posted: 2014-07-19
Terminated: 2014-10-15
Recalling firm: Stryker Corp.
Product: Disposable StrykeFlow Tip, Stryker Disposable Suction/I irrigator Tip; Sterile, Rx only, Latex Free. Stryker Suction Irrigation system, used to provide a clean and clear operative site through the evacuation and aspiration of irrigant solution. for endoscopic use.
Product code: LJH System, Irrigation, Urological
Reason for recall: Internal review found that six lots of Disposable StrykeFlow Tips were shipped with a potentially deformed blister pouch which could impact sterility of the product.
Root cause tag: packaging
FDA root cause: Other
Action: Stryker sent an Urgent Device Removal letter via certified mail on June 20, 2014 to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to return any unused product, inform individuals within their organization who need to aware of the device removal. Customers with questions were instructed to call 1-800-624-4422. For questions regarding this recall call 408-754-2664.
Quantity in commerce: 496 boxes (6 tips per box)
Distribution: Worldwide Distribution - USA (nationwide) and Internationally tAustralia, Canada, France, Greece, Netherlands, United kingdom and South Korea.
Product codes and lots: P/N 0250070505; Lot numbers: 14021FG2, 13337FG2, 13343FG2, 13347FG2, 14007FG2, 14016FG2.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2080-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2080-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-30	2014-07-18

Product code LJH

K042457Class IIUro ProW.O.M. World of Medicine AG / cleared 2004-10-25

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)